Condition category
Digestive System
Date applied
08/07/2018
Date assigned
11/07/2018
Last edited
17/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In recent years, dental lasers have been used for the non-surgical treatment of periodontal (gum) diseases. However, it is unclear whether lasers are effective at improving treatment for chronic periodontitis (inflammation of the gums). This study aims to determine whether the use of a laser called Er:YAG is more effective than the traditional treatment of scaling and root planing (SRP) for periodontal diseases in a Chinese population.

Who can participate?
Chronic periodontitis patients aged between 35-70 in Beijing

What does the study involve?
The study design involves splitting the patient's mouth into two sides - a test side and a control side. Teeth were randomly allocated into the test side or the control side i.e. if teeth on the left hand side were allocated test group, the right hand side will be the control group. Participants in the test group will receive laser treatment and traditional SRP treatment, whereas participants in the control group will receive traditional SRP treatment only. To determine the effectiveness of the treatment, participants will have a clinical examination involving assessment of their probing depth, clinical attachment level, bleeding index and plaque index. For the test and control groups, treatment will occur at 0 months, 3 months and 6 months. Treatment will occur after a clinical examination.

What are the possible benefits and risks of participating?
A benefit of participating is that patients will receive traditional periodontal treatment, along with free laser treatment for those in the test group. There is the risk of a small amount of pain in the gum for 1-2 days after treatment.

Where is the study run from?
Department of Stomatology, Beijing Chao-Yang Hospital, Beijing

When is the study starting and how long is it expected to run for?
March 2015 to December 2017

Who is funding the study?
1. The Beijing Science and Technology Committee (China)
2. National Natural Science Foundation of China (China)

Who is the main contact?
Prof. Zhou
xuanzhou2004@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Xuan Zhou

ORCID ID

http://orcid.org/0000-0003-2522-1283

Contact details

Department of Stomatology
Beijing Chao-Yang Hospital
Capital Medical University
Chao Yang District
Beijing
100020
China

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

N/A

Protocol/serial number

Z151100004015100

Study information

Scientific title

Efficacy of Er:YAG laser on chronic periodontitis as an adjunctive non-surgical treatment: a split-mouth randomized controlled study

Acronym

Er:YAG laser in Periodontal Treatment

Study hypothesis

Er:YAG laser combined with conventional scaling and root planing (SRP) may provide more effective adjunctive treatment than SRP alone

Ethics approval

Ethics Committee of the Beijing Chao-Yang Hospital, 14/11/2014, No: 2014-Sci-157

Study design

Interventional single-blinded single centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Moderate or severe chronic periodontitis

Intervention

Using a split-mouth design, two quadrants (one quadrant from each jaw) were randomly allocated to either the test or control group. The quadrants in the test group received Er:YAG laser (ERL) plus scaling and root planing (SRP) treatment, while the quadrants in the control group received SRP only.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Periodontal probing was used to measure the following at the baseline, after 3 months and after 6 months:
1. Probing depth (PD)
2. Clinical attachment level (CAL)

Secondary outcome measures

The following were measured at the baseline, after 3 months and after 6 months:
1. Bleeding index (BI) assessed through periodontal probing
2. Plaque index (PLI) assessed by an examiner using a scale of 0 to 3 with the following definitions:
- 0: No plaque
- 1: Cannot see plaque but plaque can be detected with probe
- 2: Moderate plaque can be seen
- 3: Lots of plaque can be seen

Overall trial start date

01/11/2014

Overall trial end date

31/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 35-70 years
2. Minimum of 16 teeth (4 per quadrant)
3. At least one site with probing depths (PD) ≥4 mm in each quadrant, with bleeding on probing
4. Good general health
5. Non-smoker

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

27

Participant exclusion criteria

Possible participants were excluded if they 1) had received periodontal treatment within the previous 6 months; 2) had received systemic antibiotic therapy within the previous 6 months; 3) had suffered systemic diseases that could influence the outcome of therapy, such as diabetes mellitus or blood disease; 4) were pregnant; or 5) were smokers.

1. Received periodontal treatment within the previous 6 months
2. Received systemic antibiotic therapy within the previous 6 months
3. Suffered systemic diseases that could influence therapy outcome (e.g. diabetes mellitus, blood disease)
4. Pregnant

Recruitment start date

01/03/2015

Recruitment end date

30/04/2017

Locations

Countries of recruitment

China

Trial participating centre

Department of Stomatology, Beijing Chao-Yang Hospital, Capital Medical University
No.8 GongRenTiYuChangNanLu, Department of Stomatology, Beijing Chao-Yang Hospital, Capital Medical University, Chao Yang District
Beijing
100020
China

Sponsor information

Organisation

Beijing Chao-Yang Hospital, Capital Medical University

Sponsor details

No.8 GongRenTiYuChangNanLu
Department of Stomatology
Beijing Chao-Yang Hospital
Capital Medical University
Chao Yang District
Beijing
100020
China

Sponsor type

Hospital/treatment centre

Website

http://www.bjcyh.com.cn/

Funders

Funder type

Not defined

Funder name

the Beijing Science and Technology Program Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

the National Natural Science Foundation of China

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intending to publish in the Journal of Clinical Periodontology in 2019

Intention to publish date

01/02/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes